China NMPA Product Recall - Fully Automated Enzyme Immunoassay System

Bio-Rad Biomedical Products (Shanghai) Co., Ltd. initiated a voluntary recall of its Fully Automated Enzyme Immunoassay (ELISA) Systems, as announced by the National Medical Products Administration (NMPA) on February 21, 2017. This action was not prompted by an NMPA inspection but rather by the company's own discovery of a critical issue: the affected products may malfunction during use. Such malfunctions could lead to unreliable and invalid test results, posing a significant concern for diagnostic accuracy and patient care. The recall has been classified as Level III, indicating that while adverse health consequences are unlikely, the potential for incorrect diagnoses due to faulty equipment warrants immediate corrective action. Under the oversight of the NMPA, Bio-Rad is systematically retrieving the implicated devices from the market. Detailed information, including specific models, specifications, and batch numbers of the recalled systems, is available in the accompanying Medical Device Recall Event Report Form. This proactive measure by Bio-Rad, managed within the NMPA's comprehensive medical device regulatory framework, ensures the integrity of diagnostic testing and upholds standards for public health and safety.